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CSA-SA(POC)

Objective

ALK positive cancer such as Anaplastic Large Cell Lymphoma (ALCL), Non small Cell Lung Carcinoma (NSCLC) and neuroblastoma are important cancers of children and adults, currently treated with standard chemotherapy and radiotherapy, with unpredicatable and poor results, in particular in the case of NSCLC and neuroblastoma. In August 2011, the US Food and Drug Administration (FDA) had an accelerated approval of a novel drug (called Crizotinib) to treat NSCLC that express abnormal ALK protein. Phase II and III clinical trials are ongoing to test the same drug in ALCL and neuroblastoma. However, it is now clear that the treatment with Crizotinib has a good initial efficacy and response, but the cancer inevitably relapses because of the occurrence of drug resistance. This resistance is due to selection of ALK point mutants that no longer bind the inhibitor. New drugs to tame the resistant cells will be probably developed in the future (as happened for Gleevec and second and third generation of BCR-ABL inhibitors), but it is expected that again resistance will emerge.As part of a research conducted under an ERC Starting Grat, we developed a new therapy for ALK positive ALCL, NSCLC and neuroblastoma based on the generation of a potent and specific anti-tumor response based on the development of an ALK-targeted immune response. This specific anti-ALK immune response is achieved by an anti-ALK vaccination in preclinical mouse models of ALCL and NSCLC. Now, in this Proof-of-Concept grant, we propose to take the next steps to move our invention toward a clinical application in human patients, by testing GLP formulations of the vaccine, its potential toxic effects and by searching the market for companies interested in its development and commercialization. Our goal is to understand and finalize the best strategy to move this experimental therapy to the market and generate a partnership with a pharma company.